FDA Considering End to Exemption From Device Labeling Requirements for Medical Procedure Kits
The Food and Drug Administration is seeking comments by April 4 on a proposed policy change that would subject certain medical procedure kits to unique device identifier data submission and labeling requirements, it said (here). Outlined in a draft guidance released on Jan. 4 (here), FDA’s new draft definition for medical device “convenience kits,” which are currently exempt from some UDI requirements, would exclude kits containing devices that are meant to be reused or replaced.
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Under FDA’s current policy, medical procedure kits are considered “convenience kits,” even though the surgeon may only use some of the devices included and replace those used, or sterilize the devices used for subsequent reuse. Devices packaged within the immediate container of a convenience kit are excepted from UDI labeling requirements, provided that the label of the convenience kit bears a UDI. According to FDA, interpreting the term “convenience kit” to include implantable devices and instruments that must be reconfigured and sterilized “would be inconsistent” with the term’s regulatory definition.
FDA is proposing a new definition for convenience kit as “two or more different medical devices packaged together for the convenience of the user where they are intended to remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user.” The draft guidance includes examples of devices that would or would not be considered convenience kits under the proposed new definition.
(Federal Register 01/04/16)